A Study to Assess S-309309 in Healthy and Obese Participants

Obesity Clinical Trial

Official title: A Phase 1 Randomized, Double-blind, Single and Multiple-dose Study to Assess the Safety, Tolerability, Pharmacokinetics, Food Effect, and Drug-Drug Interactions of S-309309 in Healthy and Obese Adult Study Participants

Status Completed

Clinical Trial Summary

The primary aim of the study is to assess the safety and tolerability of S-309309 after oral administration in healthy adult or obese but otherwise healthy adult participants. The secondary aim of the study is to assess the pharmacokinetics of S-309309 and the effects on ECG parameters after oral administration in healthy or obese but otherwise healthy participants.

Clinical Trial Description

This study will consist of 2 Parts. Part 1 will include healthy participants who will be assigned to a dose group. Participants will then be randomized to receive a single oral administration of S-309309 or placebo in a fasted state. Administration will be initiated in the lowest dose group, and administration in the next dose group will not occur until a review of safety and tolerability has been completed for the preceding group.

Part 2 will include 2 groups. Healthy participants and obese but otherwise healthy participants will receive multiple oral administrations of S-309309 or placebo in a fed state. ;

Related Conditions & MeSH terms

• Obesity

• NCT number: NCT05247970
• Study type: Interventional
• Source: Shionogi Inc.
• Status: Completed
• Phase: Phase 1
• Start date: January 4, 2022
• Completion date: November 1, 2022